With vaccine experts warning the US federal government against rushing out a coronavirus vaccine; and other groups pushing for a vaccine before the election; US Thalidomide Survivors are calling time out.
Politics are in play, fear, and also money — so much money. Perhaps one of the most memorable times a drug was last forced in a huge hurry upon the world, however, was in the late 1950s and early 1960s. That drug was Thalidomide.
With its origin at Chemie Grünenthal in Germany, Thalidomide hit world markets as a “perfectly safe” sedative, impossible to overdose on, and with the bonus benefit that it alleviated morning sickness for pregnant mothers. In the United States, American pharmaceutical company Richardson Merrell was licensed to produce the drug. In anticipation of swift FDA approval, Richardson Merrell distributed more than 2.5 million doses of thalidomide to more than 1,200 U.S. doctors, who then gave it to an estimated 20,000 unsuspecting patients. Company executives believed the drug would be approved by November 1960. With the distribution of samples, they hoped to advance awareness of the new tranquilizer and maximize the number of prescriptions written during the most anxious time of the year: the Christmas and New Year’s holidays.
FDA approval never came. With the millions of pills already distributed, the news broke that Thalidomide had been linked to serious birth defects in babies whose mothers had been given the drug. Deformities of the arms and/or legs (phocomelia) were most common, but additional injuries to the kidneys, heart, gastrointestinal tract, reproductive organs, ears and eyes were sometimes not discovered until decades later.
With an estimated 40% infant death rate and an unknown number of miscarriages, the damage caused by the reckless distribution of thalidomide samples to pregnant women in the United States is staggering. The toll in the US is a number that is still being tallied.
A COVID-19 vaccine must not be rushed to market. US Thalidomide Survivors remember — daily — all too well the lessons we should have learned from history.
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